Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s
health innovation, today reported financial results for the first
quarter ended March 31, 2020 and provided a company update.
“The first quarter was an active one for Daré,
beginning with the commercial licensing agreement with Bayer for
Ovaprene and continuing with important progress in advancing the
development of each of our later-stage product candidates,” said
Sabrina Martucci Johnson, President and CEO of Daré Bioscience.
“There is continued uncertainty with respect to the impact of the
COVID-19 pandemic on businesses and economies across the world.
However, we are on track to start the DARE-BV1 pivotal clinical
study in July and report topline data for the study before the end
of the year. In addition, we currently believe that we will
be able to report topline data for our planned Phase 2b study of
Sildenafil Cream, 3.6% in female sexual arousal disorder in 2021
and topline data for our planned pivotal contraceptive study of
Ovaprene in 2022. On today’s conference call, we plan to review
meaningful updates on our later-stage clinical programs, recent
financing developments and the innovative alliance with Health
Decisions that we announced on Monday and that we believe will
accelerate our clinical development efforts in a time and
cost-efficient manner.”
First Quarter 2020 Business
Highlights
- Ovaprene® – License agreement with
Bayer for the U.S. commercial rights to our investigational
hormone-free, monthly contraceptive.
- DARE-BV1 – FDA Fast Track Designation
for the treatment of bacterial vaginosis; preparations for Phase 3
study this year.
- Sildenafil Cream, 3.6% – Positive data
from thermography study presented at the International Society for
the Study of Women’s Sexual Health (ISSWSH) Annual Meeting
2020.
First Quarter 2020 Financial
Results
- General and administrative expenses
were approximately $1.9 million for the first quarter of 2020, as
compared to approximately $1.3 million for the first quarter
of 2019, with the increase due primarily to increased expenses for
accounting, legal and professional services and higher personnel
and insurance costs.
- Research and development expenses
were approximately $2.4 million for the first quarter of
2020, as compared to approximately $1.7 million for the
first quarter of 2019. The increase was due primarily to expenses
related to development activities for DARE-BV1, Ovaprene,
DARE-HRT1, and DARE-VVA1, and for the microchip-based contraceptive
program acquired in the fourth quarter of 2019, and increased
personnel costs, with such expenses partially offset by grant
funding related to both Ovaprene and the microchip-based
contraceptive program.
- License expenses, which reflect
payments due under Daré’s various product license agreements, were
approximately $12,500 for the first quarter of 2020, as compared to
$112,500 for the first quarter of 2019.
- Comprehensive loss for the first
quarter of 2020 was approximately $4.3 million, as compared to
approximately $3.0 million for the same period in the prior
year substantially due to a greater loss from operations in the
first quarter of 2020.
- Net cash provided by financing
activities for the first quarter of 2020 was approximately
$6.9 million and consisted of net proceeds from sales of
common stock in “at-the-market” offerings and proceeds from
exercises of warrants and options.
- Cash and cash equivalents were
approximately $5.0 million at March 31, 2020, compared to
approximately $4.8 million at December 31, 2019.
Recent Developments
- Third Notice of Award of approximately
$731,000 in grant funding received from the National Institutes of
Health for the Ovaprene program, with $428,000 of that amount
received after March 31, 2020 as reimbursement of Ovaprene
postcoital test clinical study expenses.
- Additional cash of approximately $2.0
million (net of fees) raised after March 31, 2020 from sales of
common stock in “at-the-market” offerings. As of May 12, 2020,
approximately 26.6 million shares of Daré common stock are
outstanding.
- Execution of a purchase agreement with
Lincoln Park Capital Fund, LLC for the potential sale of up to $15
million in shares of Daré common stock over a 36-month period at
times and in amounts controlled by Daré, subject to the
satisfaction of conditions in and the limitations under the
agreement.
- Announcement of a partnership
agreement with Health Decisions, Inc., a full-service contract
research organization (CRO) with expertise in clinical development
of women’s health products, intended to facilitate advancement of
key Daré programs in a capital-efficient manner.
COVID-19 Update: Daré continues to monitor the
pandemic, its associated restrictions and their potential effects
on the company’s business, financial condition and results of
operations, including the potential impacts on the company’s
planned clinical trials and its ability to raise additional capital
when needed. Due to rapidly evolving circumstances, Daré is unable
to predict with any reasonable accuracy the full financial and
business impact of the pandemic on its business, financial
condition or results of operations at this time.
Conference Call
Daré will host a conference call and live webcast
today at 4:30 p.m. Eastern Time to review the company's
financial results for the quarter ended March 31, 2020 and to
provide a company update.
To access the conference call via phone, dial (844)
831-3031 (U.S.) or (443) 637-1284 (international). The conference
ID number for the call 3387116. The live webcast can be accessed
under “Events & Presentations" in the Investor Relations
section of the company's website at www.darebioscience.com.
Please log in approximately 5-10 minutes prior to the call to
register and to download and install any necessary software. To
access the replay, please call (855) 859-2056 (U.S.) or (404)
537-3406 (international). The conference ID number for the replay
is 3387116. The call and webcast replay will be available
until May 21, 2020.
About Daré Bioscience
Daré Bioscience is a clinical-stage
biopharmaceutical company committed to the advancement of
innovative products for women’s health. The company’s mission is to
identify, develop and bring to market a diverse portfolio of
differentiated therapies that expand treatment options, improve
outcomes and facilitate convenience for women, primarily in the
areas of contraception, vaginal health, sexual health, and
fertility.
Daré’s product portfolio includes potential
first-in-category candidates in clinical development: Ovaprene®, a
hormone-free, monthly contraceptive intravaginal ring
whose U.S. commercial rights are under a license
agreement with Bayer; Sildenafil Cream, 3.6%, a novel cream
formulation of sildenafil to treat female sexual arousal disorder
utilizing the active ingredient in Viagra®; DARE-BV1, a unique
hydrogel formulation of clindamycin phosphate 2% to treat bacterial
vaginosis via a single application; and DARE-HRT1, a combination
bio-identical estradiol and progesterone intravaginal ring for
hormone replacement therapy following menopause. To learn more
about Daré’s full portfolio of women’s health product candidates,
and mission to deliver differentiated therapies for women, please
visit www.darebioscience.com.
Daré may announce material information about its
finances, product candidates, clinical trials and other matters
using its investor relations website
(http://ir.darebioscience.com), SEC filings, press
releases, public conference calls and webcasts. Daré will use these
channels to distribute material information about the company, and
may also use social media to communicate important information
about the company, its finances, product candidates, clinical
trials and other matters. The information Daré posts on its
investor relations website or through social media channels may be
deemed to be material information. Daré encourages investors, the
media, and others interested in the company to review the
information Daré posts on its investor relations website
(https://darebioscience.gcs-web.com/) and to follow these Twitter
accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the
list of social media channels the company may use to communicate
information will be posted on the investor relations page of Daré’s
website mentioned above.
Forward-Looking Statements
Daré cautions you that all statements, other than
statements of historical facts, contained in this press release,
are forward-looking statements. Forward-looking statements, in some
cases, can be identified by terms such as “believe,” “may,” “will,”
“estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,”
“could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,”
“contemplate,” project,” “target,” “tend to,” or the negative
version of these words and similar expressions. Such statements
include, but are not limited to, statements relating to Daré’s
expectations for clinical development of its product candidates,
including the timing of commencement and announcement of topline
results of planned clinical studies of DARE-BV1, Sildenafil Cream,
3.6% and Ovaprene, the potential for regulatory approval to market
DARE-BV1 and Ovaprene based on a single successful Phase 3 study or
contraceptive effectiveness and safety clinical study,
respectively, Daré’s ability to access up to $15 million in
additional capital under its purchase agreement with Lincoln Park
Capital Fund at times and in amounts its desires and Daré’s
expectations that its partnership agreement with Health Decisions
will accelerate clinical development of its programs and result in
cost-savings. Forward-looking statements involve known and
unknown risks, uncertainties and other factors that may cause
Daré’s actual results, performance or achievements to be materially
different from future results, performance or achievements
expressed or implied by the forward-looking statements in this
press release, including, without limitation, risk and
uncertainties related to: the effects of the COVID-19 pandemic on
Daré’s operations, financial results and condition, and ability to
achieve current plans and objectives, including the potential
impact of the pandemic on the ability of third parties on which
Daré relies to assist in the conduct of its business, including its
clinical trials, to fulfill their contractual obligations to Daré;
Daré’s ability to raise additional capital when and as needed to
advance its product candidates and continue as a going concern;
Daré’s ability to satisfy the conditions in its purchase agreement
to sell shares of its common stock to Lincoln Park Capital Fund and
the effect of the limitations in the purchase agreement on such
sales and on Daré’s ability to engage in any variable rate
transactions to raise additional capital; Daré’s ability to
develop, obtain regulatory approval for, and commercialize its
product candidates; the failure or delay in starting, conducting
and completing clinical trials or obtaining FDA or foreign
regulatory approval for Daré’s product candidates in a timely
manner; Daré’s ability to conduct and design successful clinical
trials, to enroll a sufficient number of patients, to meet
established clinical endpoints, to avoid undesirable side effects
and other safety concerns, and to demonstrate sufficient safety and
efficacy of its product candidates; the risk that positive findings
in early clinical and/or nonclinical studies of a product candidate
may not be predictive of success in subsequent clinical studies of
that candidate; Daré’s ability to retain its licensed rights to
develop and commercialize a product candidate; Daré’s ability to
satisfy the monetary obligations and other requirements in
connection with its exclusive, in-license agreements covering the
critical patents and related intellectual property related to its
product candidates; the risks that the license agreement with Bayer
may not become effective and, if it becomes effective, that future
payments to Daré under the agreement may be significantly less than
the anticipated or potential amounts; developments by Daré’s
competitors that make its product candidates less competitive or
obsolete; Daré’s dependence on third parties to conduct clinical
trials and manufacture clinical trial material; Daré’s ability to
adequately protect or enforce its, or its licensor’s, intellectual
property rights; the lack of patent protection for the active
ingredients in certain of Daré’s product candidates which could
expose its products to competition from other formulations using
the same active ingredients; the risk of failure associated with
product candidates in preclinical stages of development that may
lead investors to assign them little to no value and make these
assets difficult to fund; and disputes or other developments
concerning Daré’s intellectual property rights. Daré’s
forward-looking statements are based upon its current expectations
and involve assumptions that may never materialize or may prove to
be incorrect. All forward-looking statements are expressly
qualified in their entirety by these cautionary statements. For a
detailed description of Daré’s risks and uncertainties, you are
encouraged to review its documents filed with
the SEC including Daré’s recent filings on Form 8-K, Form
10-K and Form 10-Q. You are cautioned not to place undue reliance
on forward-looking statements, which speak only as of the date on
which they were made. Daré undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made, except as required by
law.
Contacts:
Investors on behalf of Daré Bioscience, Inc.:Lee
Roth Burns McClellan lroth@burnsmc.com 212.213.0006
OR
Media on behalf of Daré Bioscience, Inc.:Jake
Robison Canale Communications jake@canalecomm.com
619.849.5383
Source: Daré Bioscience, Inc.
Daré Bioscience, Inc. and Subsidiaries |
Consolidated Statements of Operations and Comprehensive
Loss |
(Unaudited) |
|
Three Months Ended March 31, |
|
|
2020 |
|
|
|
2019 |
|
Operating expenses: |
|
|
|
General and administrative |
$ |
1,861,765 |
|
|
$ |
1,277,180 |
|
Research and development expenses |
|
2,379,804 |
|
|
|
1,693,391 |
|
License expenses |
|
12,500 |
|
|
|
112,500 |
|
Total operating expenses |
|
4,254,069 |
|
|
|
3,083,071 |
|
Loss from operations |
|
(4,254,069 |
) |
|
|
(3,083,071 |
) |
Other income |
|
1,821 |
|
|
|
31,231 |
|
Net loss |
$ |
(4,252,248 |
) |
|
$ |
(3,051,840 |
) |
Foreign currency translation adjustments |
$ |
(22,944 |
) |
|
$ |
7,621 |
|
Comprehensive loss |
$ |
(4,275,192 |
) |
|
$ |
(3,044,219 |
) |
Loss per common share - basic and
diluted |
$ |
(0.18 |
) |
|
$ |
(0.27 |
) |
Weighted average number of common
shares outstanding: |
|
|
|
Basic and diluted |
|
23,799,396 |
|
|
|
11,422,161 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Daré Bioscience, Inc. and Subsidiaries |
Condensed Consolidated Balance Sheets |
|
March 31, |
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
(unaudited) |
|
|
Cash and cash equivalents |
$ |
5,047,325 |
|
|
$ |
4,780,107 |
|
Working capital |
$ |
4,606,229 |
|
|
$ |
831,526 |
|
Total assets |
$ |
10,213,965 |
|
|
$ |
7,442,788 |
|
Total liabilities |
$ |
6,999,782 |
|
|
$ |
7,001,962 |
|
Total stockholders'
equity |
$ |
3,214,183 |
|
|
$ |
440,826 |
|
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